MAUDE Adverse Event Report: MEDTRONIC B.V. ATTAIN STABILITY; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

Model Number 20066

Device Problems Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/18/2014

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during the implant procedure, the physician attempted to fixate the left ventricular (lv) three or more times.It was noted that the lead had to be re-anchored from the initial position twice due to unsuitable electrical parameters.The lead was ultimately placed successfully and remains in use.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN STABILITY
• Type of Device: DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC B.V.; earl bakkenstraat 10; heerlen 6422 PJ; NL 6422 PJ
• Manufacturer (Section G): MEDTRONIC B.V.; earl bakkenstraat 10; heerlen 6422 PJ; NL 6422 PJ
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8118443
• MDR Text Key: 128909044
• Report Number: 3002807561-2018-00022
• Device Sequence Number: 1
• Product Code: OJX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P080006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: 20066
• Device Catalogue Number: 20066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Date Device Manufactured: 04/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR